Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

03 Jul 2022
Massachusetts, Woburn, 01801 Woburn USA

Senior Quality Assurance Specialist

Vacancy expired!

Sr. Quality Assurance Specialist

  • Woburn MA (100% onsite)

  • Contract to Direct Hire
  • Rates Depending on experience

The Sr. QA Specialist will be responsible for daily QA tasks at the direction and under the supervision of the Manager of Quality Systems to support the development, implementation, and maintenance of the company quality assurance program. The Sr. QA Specialist may perform initial review and preparation of records and events, but is not responsible or authorized to perform technical approvals, high-level Quality decisions, or release of GxP material or documentation, except where specifically authorized in writing by the Quality Systems Manager.

Primary Responsibilities Include:

  • Actively contribute to all Quality Systems such as Deviations, Change Control, Out-of-Specifications, CAPA, Training, and Risk Assessments

  • Collaborate with other departments to fully support Equipment Qualification and Calibration programs

  • Involvement with controlled document systems, including authoring and revising SOPs

  • Lead or assist with continuous improvement initiatives across all GMP functions
  • Lead or assist in auditing and investigation activities, perform root-cause analyses, and help to develop corrective and preventative action plans

  • Preparation of trend reports across Quality Systems, as needed

  • Provide support during Regulatory inspections and client audits

  • Assist in maintaining the facility in an inspection-ready state

Job Qualifications and Requirements

  • A Bachelor's degree in Science, preferably in biology or similar field

  • At least two years of working within the pharmaceutical or biotechnology industry, in a GMP environment

  • GLP experience preferable

  • Strong understanding of GMPs

  • Quality Systems experience in GMP environment
    An ability to organize, understand, and present complex scientific and technical information at a level that is appropriate for technical and non-technical backgrounds
    Attention to detail and analytical thinking
    Excellent communication and interpersonal skills
    Excellent organizational skills
    Experience in Regulatory Inspection participation a plus

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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